FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIFELINES PHOTIC STIMULATOR
K Number: K101691
·
Decision Aug 10, 2010
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
48
Applicant Total
4
Review Days
55
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Basic Information
- Device Name
- LIFELINES PHOTIC STIMULATOR
- K Number
- K101691
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lifelines , Ltd.
- Date Received
- June 16, 2010
- Decision Date
- August 10, 2010
- Product Code
- GWE
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GWE | Stimulator, Photic, Evoked Response | FDA class 2 | Neurology |
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